Location: Allentown, PA
Department: Azzur IT, LLC
Department: Azzur IT, LLC
We at Azzur Group are looking for an experienced Regional Product Support QA Validation Consultant to join our team.Responsibilities:
- Leads or manage documentation reconciliation, quality review and follow up observation close out items
- Will be responsible for daily reporting of events from the day, and overall management of digital approval and reconciliation of forms generated by the Quality and Operations units at the site
- Support activities related to quality oversight activities
- Provides guidance define objectives, deliverables, ownership, due dates, and effectiveness requirements
- Technical leadership will be required to ensure that product and process understanding is sufficient to understand process observations, are technically sound, meet quality expectations, and that corrective actions completed.
- Supports process monitoring as needed
- Collaborates with cross-functional teams on department-specific trend.
- Provides guidance to team for performing a deep-dive analysis of department-specific trends
- Conducts data gathering, trending, and data presentation as needed to support Oversight activities
- Should have an advanced understanding of Excel and SharePoint applications, and be able to perform simple data analysis and trending on data sets.
- Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
- US vaccines point of contact for EQ and Platform improvement initiatives as well as issue management
- EQ Process input and programs (data integrity, FFP, etc.)
- Compliance Network & Visual Inspection Community of Practice
- Connection with Vaccines Investigation team –view of trends/hypercare
- Supplier issues, cross site issues (escalations)
- Key stakeholder connection points (PQM, EQ, BQ, JJRC, RA, PES, TO, VPAD, Site Quality)
- Conduct gap assessments (site observations, benchmarking)
- Facilitate awareness/refresher training
- FPX training
- Manage holistic review of changes with market restrictions
- Specific projects
- PAI readiness
- Vial qualification
- Site specific projects/improvements
- Handling of particles
- Batch Tagging team
- Introduction of on-soil testing
- Approver on global changes
- BLA point of contact
- Onboarding of new employee
- 5+ years of experience in execution and/or approval of quality records.
- Expertise in a quality assurance or technical role within a GMP manufacturing environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology, pharmaceutical, and manufacturing industries.
- Experience with using complex Data analysis tools and methodologies.
- Advanced understanding of Excel and SharePoint applications,
- Demonstrated excellence in technical presentation skills.